Prescription drug · ANDA
Junel 21 Day NDC 0555-9025
norethindrone acetate and ethinyl estradiol · Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-9025-42 | 0055590254200555902542 | 3 POUCH in 1 CARTON (0555-9025-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Sep 18, 2003 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Junel 21 DaySuffix: 21 Day
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol
- Active ingredients
- Norethindrone acetate — 1 mg/1Ethinyl estradiol — 20 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076380
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0555-9025_254f2e35-bbeb-4134-8799-2d3fa959fe84SPL ID 254f2e35-bbeb-4134-8799-2d3fa959fe84SPL set ID 8b82ad14-580c-4145-b825-dce849f95363RxCUI 259176, 1358762, 1358763, 1358765, 1358776, 1358780, 1359022, 1359023, 1359025, 1359028, 1359030UNII 9S44LIC7OJ, 423D2T571U
- Pharmacologic class
- Estrogen; Progestin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400555902542followed by a unit qualifier and the quantityPackage 00555-9025-42. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % Of Women Experiencing an Unintended Pregnancy in the Fi…
Excerpt only. Read the full label for complete information.
About NDC 0555-9025
- What is NDC 0555-9025?
- 0555-9025 is the product NDC for Junel 21 Day, Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Junel 21 Day (Norethindrone Acetate and Ethinyl Estradiol).
- What is the active ingredient?
- Norethindrone acetate, Ethinyl estradiol.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Junel 21 Day?
- 2 other product NDCs are listed under this name. See all Junel 21 Day NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Junel 21 Day products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Junel 21 Daynorethindrone acetate and ethinyl estradiol | Norethindrone acetate 1.5 mg/1; Ethinyl estradiol 30 ug/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-9027 | 00555-9027-42 |
| Junel 21 Daynorethindrone acetate and ethinyl estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 | TabletOral | Proficient Rx LP | 82804-172 | 82804-0172-21 |
Other NDCs under ANDA 076380
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Junel 21 Daynorethindrone acetate and ethinyl estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 | TabletOral | Proficient Rx LP | 82804-172 |
| Junel FE | Ethinyl estradiol 20 ug/1; Norethindrone acetate 1 mg/1 | TabletOral | Direct_Rx | 72189-215 |
| Loestrin 21 Daynorethindrone acetate and ethinyl estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 | TabletOral | Teva Women's Health LLC | 51285-131 |